Post-Approval Studies (PAS)

The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

This is an observational cohort study. A new cohort of patients and physicians will be enrolled to collect procedural data on ESS305. Data from the Study for Newly Trained Physicians (completed September 2005) will be used as the comparator. The protocol also includes collection of adverse events data.The purpose of this post-approval clinical study is to determine the following: 1. Bilateral placement ofthe ESS305 micro-insert at first attempt; 2. Comparison of bilateral placement success between NewlyTrained physicians and Experienced physicians

Study population is as per device indication. This device is indicated for permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes in adult women seeking permanent birth control.

The sponsor reported only 6 adverse events occurred during and after the Essure placement procedure (6 out of 584). All reported events were minor with the exception of one case. The subject was hospitalized after hysteroscopy resulted in a uterine perforation by the hysteroscope. The sponsor claims the Essure device did not cause the injury to the patient. None of these events represent unanticipated adverse device effects.

Strengths & Weaknesses

The study is well designed to evaluate the placement rate among newly trained physicians at first attempt, when implanting the device in women seeking permanent sterilization.

Label Changes

Update labeling with the results of the study in the context of patient and physician labeling.